Avmapki Fakzynja Co-Pack (avutometinib/defactinib)
Indications for Prior Authorization
Avmapki Fakzynja Co-Pack (avutometinib/defactinib)
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For diagnosis of KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC)
Indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Criteria
Avmapki Fakzynja Co-Pack
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Ovarian Cancer
- Diagnosis of recurrent low-grade serous ovarian cancer (LGSOC) AND
- Presence of a KRAS-mutation as detected by a Food and Drug Administration (FDA) -approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA) AND
- Patient has received prior systemic therapy (e.g., chemotherapy)
Avmapki Fakzynja Co-Pack
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Ovarian Cancer
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2025-07-02
References
- Avmapki Fakzynja Co-Pack Prescribing Information. Verastem, Inc. Needham, MA. May 2025.
Revision History
- 2025-07-02: New program.